BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPNC QUICK CROSS SUPPORT CATHETER

    MDR report key: 1656160 · Received April 1, 2010

    Report

    Report Number
    1721279-2010-00015
    Event Type
    Malfunction
    Date Received
    April 1, 2010
    Date of Event
    March 1, 2010
    Report Date
    April 1, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    DQO
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE REPORTED EVENT STATED THAT THE MD WAS PREPPING THE SPNC DEVICE PRIOR TO THE PROCEDURE. AS HE FLUSHED THE CATHETER, SALINE CAME OUT OF A HOLE OR SLIT NEAR THE HUB OF THE CATHETER AND SPRAYED THE TECH IN THE FACE. A SMALL AMOUNT OF BLOOD WAS NOTICED IN THE SYRINGE THAT WAS BEING USED TO FLUSH THE CATHETER. THE TECH RINSED HER EYES. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THE DEVICE IN QUESTION HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC QUICK CROSS SUPPORT CATHETER QUICK CROSS DQO SPECTRANETICS CORP. 518-037 FQC09M14G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GENERATION 4 EXCIMER LASER